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[Optimize.WHO]

Optimizing presentation and packaging for HPV vaccines

by Debbie Kristensen and D. Scott LaMontagne, PATH

Working in collaboration with the Vaccine Presentation and Packaging Advisory Group (VPPAG), representatives from the public health community have initiated a series of studies to guide presentation and packaging decisions for future iterations of human papillomavirus (HPV) vaccines destined for low-income countries. Presentation and packaging decisions, such as the number of doses per container, type of container, and recommended storage temperatures greatly impact the way vaccines are handled, the quantity of vaccine doses wasted, and the ability of health workers to get the vaccines to remote, low-resource settings. By influencing these decisions early in the development process, public health officials can make sure that the specific needs of developing countries are considered.

HPV vaccines present unique characteristics that differentiate them from current World Health Organization (WHO)-prequalified infant vaccines. HPV vaccines target an older, gender-specific population; are currently available at higher prices than most existing WHO-prequalified vaccines; offer promising heat-stability profiles; and similar to pneumococcal vaccines, are currently available only as liquid formulations, in one- and two-dose vials, without preservative.

The following are a list of studies recently initiated to gather data from users, procurement specialists, and economists to better understand needs and constraints regarding HPV vaccines:

• A retrospective, cross-sectional analysis of data on vaccination session size from three HPV vaccine demonstration projects in Uganda, Peru, and Vietnam.
• A small-scale, time-and-motion study to assess the time and ease of vaccine delivery across different HPV vaccine presentations.
• Documentation of ambient temperatures experienced during the final stages of HPV vaccine distribution and use in Vietnam and Uganda to assess the feasibility of controlled ambient temperature storage and transport.
• Surveys with immunization program managers and health workers in Vietnam involved in the HPV vaccine demonstration project to sample preferences for HPV vaccine presentation, packaging, and logistics. (Note: similar surveys may also be conducted in Uganda and Peru).
• Breakeven analysis of potential price, wastage, and cold chain costs for various HPV vaccine presentations using the Vaccine Presentation Assessment Tool.
• Analysis of qualitative data from questionnaires that assess individual experiences of those involved in HPV vaccine demonstration project activities in Uganda, Peru, and Vietnam.

The VPPAG will compile the results of these studies and additional data available from industry into a preferred product profile for HPV vaccines describing characteristics, including optimal vial size, presentation, and storage temperature requirements, for future HPV vaccines for use in developing countries.

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[Marcia_Rock at JSI.COM]

Thank you for this useful update.

It is essential at this stage of health care service delivery, to also
consider the safe and sufficient disposal among the parameters of
optimizing presentation and packaging for future iterations of vaccines,
including for HPV. This final stage of the life cycle is now being
considered for some health care commodities. It can be the only way to
ensure that the products truly first do no harm. If possible, please
inform how this element will be included, to ensure that the
presentation and packaging optimization process is comprehensive and
complete.

Thank you in advance and with best regards for your good work.

Marcia N. Rock, MPH
Technical Officer
HCWM Focal Point
John Snow, Incorporated
1616 N. Fort Myer Drive
Arlington, VA 22209-3100
Tel (703)310-5257
Fax (703)528-7480

[drjulesmillogo]

Marcia Rock raised an excellent point. In just a few weeks (December 12,
2009), the Copenhagen Climate Council will start the discussions on policies
to reduce carbon dioxide emissions and so forth. I am sure the logisticians
in Optimize will agree that incorporating healthcare waste management
considerations at the beginning of these \"packaging\" plans would be a more
effective way of staying in line with these new policies than trying to
figure it out as an after-thought. It is in our collective interest that any
new project be -at a minimum- mindful of the new climate (literally and
figuratively) we are working in.

Jules Millogo, MD, MSc
Public Health Policy and Planning
Washington
drjulesmillogo@gmail.com

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[Marcia_Rock at JSI.COM]

Well said. Thanks.

[dkriste]

I wholeheartedly agree that disposal issues should be a major concern during the design phase of new products. The Vaccine Presentation and Packaging Advisory Group (VPPAG) is addressing the environmental impact of vaccine presentations and packaging as part of their work on a generic preferred product profile (gPPP) for vaccines (see: http://sites.google.com/site/vppagp/gppp). The profile contains the following recommendation: “Use materials for delivery devices, primary containers and secondary and tertiary packaging that minimize the environmental impact of waste disposal for resource limited systems.” In addition, the VPPAG is undertaking a work program to “Consult with industry on feasible recommendations for packaging materials as well as maximum volume recommendations for primary containers and secondary and tertiary packaging for different vaccine types and containers and advise the WHO on setting these as recommendations for prequalified vaccines.”  Thanks for raising this important issue. We hope to have further documents to share with Technet members in the near future as we develop recommendations with more specificity.   

Debra D. Kristensen

Group Leader, Vaccine Technologies

PATH

1455 NW Leary Way

Seattle, WA 98107 USA

Telephone: (206) 285-3500; Fax: (206) 285-6619

Email: dkriste@path.org; Web site: www.path.org

Before printing, consider our environment | Avant d'imprimer, pensez a l'environnement | Antes de imprimir, piense en el medio ambiente

[malarianag]

Well said. I fully agree with your views. Thanks for brnging up the
issue in a positive way. The whole group have done well in considering
such issues in the begining. Congratulations.

Nagaraj